BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC CO-BRANDED BLOOD GLUCOSE METER

    MDR report key: 490780 · Received October 17, 2003

    Report

    Report Number
    2243072-2003-00080
    Event Type
    Other
    Date Received
    October 17, 2003
    Date of Event
    September 17, 2003
    Report Date
    October 15, 2003
    Manufacturer
    BECTON DICKINSON
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS HIGH READINGS WITH ONE VIAL OF STRIPS. ANALYSIS RUN ON CLARKE ERROR GRID USING COMPETITIVE METER READINGS (39,205) AS REF POINTS VS. BD READINGS (200, 425) YIELDED DATA POINTS IN THE E/C RANGES OF THE GRID, OUTSIDE ACCEPTABLE RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD LOGIC CO-BRANDED BLOOD GLUCOSE METER BD TEST STRIPS CFR BECTON DICKINSON NA 2071325

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other